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Continuous Correction

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ClinicalTrials.gov Identifier: NCT02162004
Recruitment Status : Terminated (Technical problems)
First Posted : June 12, 2014
Last Update Posted : August 31, 2016
Sponsor:
Information provided by (Responsible Party):
Signe Schmidt, Hvidovre University Hospital

Tracking Information
First Submitted Date  ICMJE June 2, 2014
First Posted Date  ICMJE June 12, 2014
Last Update Posted Date August 31, 2016
Study Start Date  ICMJE June 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2014)
Percentage of time CGM values are in the target range 3.9-8.0 mmol/l in the time period 8:00-17:00. [ Time Frame: Every 5 min for 9 hours on each study day. ]
The primary outcome is difference in the percentage of time CGM values are in the target range 3.9-8.0 mmol/l in the time period 8:00-17:00 on CC-days and Control-days.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2014)
  • Mean CGM glucose value. [ Time Frame: Every 5 min for 9 hours on each study day. ]
  • Percentage of time when CGM values are < 3.9 mmol/l. [ Time Frame: Every 5 min for 9 hours on each study day. ]
  • Percentage of time when CGM values are > 8.0 mmol/l. [ Time Frame: Every 5 min for 9 hours on each study day. ]
  • CGM standard deviation. [ Time Frame: Every 5 min for 9 hours on each study day. ]
  • Number of hypoglycemic episodes. [ Time Frame: Every 5 min for 9 hours on each study day. ]
  • Amount of insulin delivered. [ Time Frame: Every 30 min for 9 hours on each study day. ]
  • Positive Incremental Area Under the Curve [ Time Frame: Every 5 min for 9 hours on each study day. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 10, 2014)
Mean absolute relative difference. [ Time Frame: Every 5 min for 9 hours on each study day. ]
CGM accuracy will be evaluated with Hemocue glucose values as reference (mean absolute relative difference).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Continuous Correction
Official Title  ICMJE Sensor-Augmented Continuous Correction in Insulin Pump-Treated Type 1 Diabetes
Brief Summary

The potential of currently available diabetes technologies could be further exploited. The investigators propose that sensor-augmented insulin pump therapy may be improved by continuous correction, i.e. continuous evaluation of the need for correction boluses. In practice, this is carried out by running the bolus calculator every 10 minutes. The glucose sensor will provide the bolus calculator with glucose input. Many times, the bolus calculator will come to the result that no insulin is needed. However, when the blood glucose is above the pre-set target value and a correction bolus is needed, an appropriate bolus is automatically delivered by the insulin pump.

The investigators hypothesize that sensor-augmented continuous correction insulin pump therapy can reduce hyperglycemia without increasing the risk of hypoglycemia in patients with type 1 diabetes.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE Procedure: Continuous Correction
Study Arms  ICMJE
  • Experimental: Continuous correction
    The insulin pump is set to automatically deliver the patient's usual insulin basal rate. The insulin pump bolus calculator is run every 10 minutes by the attending physician. Bolus calculations are based on glucose sensor values.
    Intervention: Procedure: Continuous Correction
  • No Intervention: Control
    Regular sensor-augmented pump therapy.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 10, 2015)
2
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2014)
12
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 years
  • T1D ≥ 3 years
  • CSII ≥ 1 year
  • HbA1c ≤ 8.0% (64 mmol/mol)

Exclusion Criteria:

  • Pregnancy or nursing
  • Hypoglycemia unawareness
  • Gastroparesis
  • Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during or within 30 days prior to the study
  • Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02162004
Other Study ID Numbers  ICMJE CC2014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Signe Schmidt, Hvidovre University Hospital
Study Sponsor  ICMJE Hvidovre University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Signe Schmidt, MD, PhD Hvidovre University Hospital
PRS Account Hvidovre University Hospital
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP